Infinium Medical, Inc recalls CLEO Patient Monitor /Tranquility VS Patient Monitor
- Recall date
- May 31, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1926-2019
- FDA classification
- Class II
- Brand / firm
- Infinium Medical, Inc
- Sold / distributed
- Distributed nationwide to California, Georgia, Louisiana, Florida, Maryland, Minnesota, Puerto Rico, South Carolina, Virginia, Wisconsin.
Why it was recalled
The CLEO & Tranquility VS Patient Monitors 510(k) indications for use in the United States did not include the temperature monitor accessory option.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
CLEO Patient Monitor /Tranquility VS Patient Monitor
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